Intraoperative Peripheral Nerve Stimulation

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07592065
Status
Withdrawn

Conditions

  • Compression Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nerve Root Electrical Stimulation — DEVICE
    in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery
  • Peripheral Nerve Electrical Stimulation — DEVICE
    in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery
  • Standard Treatment - Nerve Root — OTHER
    standard surgical treatment when undergoing spine surgery for decompression of the nerve root
  • Standard Treatment - Peripheral Nerve — OTHER
    standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity

Study Details

The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.

Key Dates

First listed
May 18, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nerve Root Stimulation Arm
    patients undergoing spine surgery for decompression of the nerve root
  • Experimental: Peripheral Nerve Stimulation Arm
    patients undergoing peripheral nerve decompression in an upper extremity
  • Active Comparator: Nerve Root Control Arm
    patients undergoing spine surgery for decompression of the nerve root
  • Active Comparator: Peripheral Nerve Control Arm
    patients undergoing peripheral nerve decompression in an upper extremity

Primary Outcome Measure

Medical Research Council Scale for Muscle Strength Score [ Time Frame: Baseline ]

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